ISO 9001:2008 Requirements Summary - 9000 Store

1 Distributed by Whittington & Associates, LLC Page 1 ISO 9001:2008 Requirements Summary In Plain English Created by Larry Whittington RABQSA Lead QMS Auditor (2406) IRCA Lead QMS Auditor (A6472) ASQ Senior Member Whittington & Associates, LLC Distributed by Part of standards Stores Network Distributed by Whittington & Associates, LLC Page 2 Contents 4. Quality Management System General Requirements Establish, document, implement, and maintain a quality management system. Continually improve its effectiveness in accordance with ISO 9001 Requirements . Implement the system to: Determine processes needed for the quality management system (and their application throughout the organization) Determine process sequence and interaction Determine criteria and methods for process operation and control Ensure resources and supporting information are available Monitor, measure where applicable, and analyze these processes Implement actions to achieve planned results and continual process improvement Manage these processes in accordance with ISO 9001 Requirements .

2 Define the type and extent of control applied to any outsourced processes that affect product conformity to Requirements . NOTE 1: Processes needed for the quality management system include the processes for management activities (see 5), provision of resources (see 6), product realization (see 7), and measurement, analysis, and improvement (see 8). NOTE 2: An outsourced process is a process the organization needs for its quality management system, and which the organization chooses to have performed by an external party. NOTE 3: Ensuring control over outsourced processes does not absolve your organization of the responsibility to conform to all customer, statutory, and regulatory Requirements . The type and extent of control applied to an outsourced process can be influenced by factors such as: Potential impact of the outsourced process on your organization's capability to provide product that conforms to Requirements Degree to which the control for the process is shared Capability of achieving the necessary control through the application of Distributed by Whittington & Associates, LLC Page 3 Documentation Requirements General Requirements Include in the quality management system documentation.

3 Documented statements of a quality policy and quality objectives A quality manual Documented procedures and records required by ISO 9001 Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processes NOTE 1: Where documented procedure appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the Requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to: Size of the organization and type of activities Complexity of processes and their interactions Competence of personnel NOTE 3: The documentation can be in any form or type of medium.

4 Quality Manual Establish and maintain a quality manual with: Scope of the quality management system Details and justification for any exclusions Procedures or references to the procedures Description of interaction between processes Control of Documents Control the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause Distributed by Whittington & Associates, LLC Page 4 Establish a documented procedure to: Approve documents for adequacy prior to issue Review, update as necessary, and re approve documents Identify the changes and current document revision status Make relevant documents available at points of use Ensure the documents remain legible and readily identifiable Identify external documents and control their distribution Prevent obsolete documents from unintended use Apply suitable identification if obsolete documents are retained Control of Records Establish and control records as evidence of conformity to Requirements and to demonstrate the effective operation of the quality management system.

5 Establish a documented procedure to define the controls needed for record: Identification Storage Protection Retrieval Retention Disposition Keep records legible, readily identifiable, and retrievable. 5. Management Responsibility All Requirements in clause 5 are the responsibility of top management. Management Commitment Provide evidence of management commitment to develop and implement the quality management system, as well as, continually improve its effectiveness by: Expressing the importance of meeting Requirements Establishing the quality policy and quality objectives Conducting management reviews Ensuring the availability of necessary resources Distributed by Whittington & Associates, LLC Page 5 Customer Focus Ensure customer Requirements are determined and met in order to improve customer satisfaction.

6 Quality Policy Ensure the quality policy is: Appropriate to the purpose of the organization Focused on meeting Requirements and continual improvement Used as a framework for quality objectives Communicated and understood at appropriate levels Reviewed for continuing suitability Planning Quality Objectives Ensure quality objectives, including those needed to meet product Requirements , are established at the relevant functions and levels within the organization. Ensure quality objectives are measurable and consistent with the quality policy. Quality Management System Planning Ensure that planning for the quality management system: Meets the general Requirements ( ), as well as, quality objectives ( ) Maintains the system integrity when changes are planned and implemented Responsibility, Authority, and Communication Responsibility and Authority Ensure responsibilities and authorities are defined and communicated within the organization.

7 Management Representative Appoint a member of your management who, irrespective of other duties, has the responsibility and authority to: Distributed by Whittington & Associates, LLC Page 6 Ensure the needed processes are established, implemented, and maintained Report to top management on quality management system performance Report to top management on any need for improvement Ensuring the promotion of awareness of customer Requirements NOTE: The responsibility of a management representative can include being the liaison with external parties on matters relating to the quality management system. Internal Communication Ensure the appropriate communication processes are established and carried out within the organization regarding the effectiveness of the system.

8 Management Review General Review the quality management system at planned intervals to: Ensure a suitable, adequate, and effective system Assess possible opportunities for improvement Evaluate the need for any changes to the system Consider the need for changes to the quality policy and objectives Maintain records of the management reviews. Review Input Inputs for management review must include information on: Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow up actions from earlier reviews Changes that could affect the quality system Recommendations for improvement Review Output Outputs from the management review must include any decisions and actions related to: Distributed by Whittington & Associates, LLC Page 7 Improvement of the effectiveness of the quality management system and its processes Improvement of product related to customer Requirements Resource needs 6.

9 Resource Management Provision of Resources Determine and provide the resources necessary to: Implement and maintain the quality management system Continually improve the effectiveness of the system Enhance customer satisfaction by meeting customer Requirements Human Resources General Ensure people performing work affecting conformity to product Requirements are competent based on the appropriate education, training, skills, and experience. NOTE: Conformity to product Requirements can be affected directly, or indirectly, by personnel performing any task within the quality management system. Competence, Training, and Awareness The organization must: Determine the competency needs for personnel Provide training (or take other actions) to achieve the necessary competence Evaluate the effectiveness of the actions taken Inform employees of the relevance and importance of their activities Ensure they know their contribution to achieving quality objectives Maintain education, training, skill, and experience records Infrastructure Determine, provide, and maintain the necessary infrastructure to achieve product conformity.

10 Infrastructure includes, as applicable: Buildings, workspace, and associated utilities Distributed by Whittington & Associates, LLC Page 8 Process equipment (both hardware and software) Supporting services (such as transport, communication, or information systems) Work Environment Determine and manage the work environment needed to achieve product conformity. NOTE: The term work environment relates to those conditions under which work is performed, including physical, environmental, and other factors such as noise, temperature, humidity, lighting, or weather. 7. Product Realization Planning of Product Realization Plan and develop the processes needed for product realization.